Adenotonsillectomy for Obstructive Sleep Apnea

UCLA, Los Angeles, CA

AdenotonsillectomyN/ARecruitingResearch Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No medications for brain disorders

Without any diagnosed neurological condition

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up6 months

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is examining the effects of sleep apnea on the brain in children.

Eligible Conditions

Pediatric Obstructive Sleep Apnea

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You are not taking any medications for brain disorders.

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You don't have any known neurological conditions.

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You are not currently receiving treatment for your breathing problem.

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Only children who are in good health can participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain tissue changes between baseline and after adenotonsillectomy.

Cognition assessment after adenotonsillectomy in pediatric obstructive sleep apnea patients.

Cognitive symptoms examination after adenotonsillectomy surgery.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 35 Pediatric Obstructive Sleep ApneaExperimental Treatment1 Intervention

The investigators will also determine whether brain tissue changes, reduced CBF, and altered neural responses to cognitive challenge reverse, and cognition and mood signs improve after standard surgical procedure "adenotonsillectomy" for breathing condition at 6 months in pediatric OSA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adenotonsillectomy

2014

N/A

~820

0 / 4Eligibility criteria met

Find a site

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,467 Previous Clinical Trials

10,148,772 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total capacity of enrollees for this clinical investigation?

"Affirmative, clinicaltrials.gov states that this medical trial is actively enrolling participants. It was first uploaded on May 14th of 2022 and has since been revised as recently as June 29th. 70 individuals are sought to take part in the study at one single site."

Answered by AI

Are there any participants still needed for this experiment?

"The evidence from clinicaltrials.gov suggests that this investigation is presently recruiting patients, with the first posting occuring on May 14th 2022 and a subsequent update on June 29th 2022."

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Is this experiment looking to involve participants aged 45 and over?

"This trial has a lower age limit of 7, and an upper bound of 12. Consequently, minors aged between these two thresholds are eligible for enrolment."

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Do I qualify to participate in this experiment?

"This investigation is inviting 70 youths between seven and twelve years of age to participate. Applicants must possess a diagnosis of obstructive [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) (AHI > 5 events/hour) that was received from an overnight polysomnography at a sleep centre, be without obesity (BMI ≥ 95th percentile for their respective age and gender), not yet have any treatments for the breathing condition, agree to undergo adenotonsillectomy surgery, as well as meet all criteria regarding sex, BMI-matched control subjects aged 7-12 years with no more than ±3 months' difference in age."

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